BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1230012 · Received November 12, 2008

    Report

    Report Number
    2029203-2008-00858
    Event Type
    Injury
    Date Received
    November 12, 2008
    Date of Event
    September 29, 2008
    Report Date
    October 13, 2008
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    A COMPLAINT REPORT WAS RECEIVED STATING THE PATIENT'S POCKET SITE HAD SWELLING. IT WAS REPORTED THAT THE PATIENT HAD SWELLING TWO WEEKS PRIOR TO INITIAL COMPLAINT AND GOT WORSE WITH TIME. PATIENT WAS ADVISED TO SEEK MEDICAL ATTENTION. UPON PHYSICIAN'S EVALUATION, THE PATIENT NO LONGER HAD SWELLING AND THERE WAS NO SIGN OF INFECTION. THE PATIENT WAS PUT ON CELEBREX. THE PATIENT REPORTS NOT HAVING PAIN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1110 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention